ACTRN12623000953639招募中Unknown
The efficacy of foot orthoses for midfoot osteoarthritis: a randomised controlled trial
a Trobe University0 个研究点目标入组 140 人开始时间: 2023年9月4日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •(i) Aged 18 years and over
- •(ii) Pain in the midfoot joints that has been present for at least 3 months, located in at least one area in a predetermined dorsal midfoot region, that is aggravated by weightbearing activities
- •(iii) Average pain in the midfoot when walking during the last 7 days is rated at least 3 out of 10 in severity on an 11-point numerical rating scale (NRS) (where 0 represents no pain and 10 represents the worst pain imaginable)
- •(iv) Have radiographic evidence of midfoot osteoarthritis confirmed using the La Trobe University Atlas of foot osteoarthritis – a minimum score of 1 for either observations of joint space narrowing or osteophytes in at least one of the midfoot joints in either radiographic view
- •(v) Able to walk household distances (>50 metres) without walking aids
- •(vi) Willing to regularly wear shoes that will accommodate shoe inserts
- •(vii) Willing to attempt to not receive additional interventions during the study period
排除标准
- •(i) Previous ipsilateral foot surgery or planning surgery in the next 12 weeks
- •(ii) Osteoarthritis secondary to other issues such as major trauma
- •(iii) Presence of other foot or ankle condition(s) or have pain in another location that is greater than the pain in the midfoot
- •(iv) Any musculoskeletal or systemic medical conditions (e.g., suspected inflammatory joint disease, neurological) that could make the participant unsuitable for inclusion or confound pain and functional assessments of the midfoot
- •(v) Any inability to speak and read English
- •(vi) Any treatment that includes the use of any foot orthoses (including shock absorption shoe inserts), ankle braces and/ or, received intra-articular injections at the midfoot in the previous 12 weeks
- •(vii) Dementia or any cognitive impairment
研究者
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